ARRHYTHMIAS Protocol Identifier Subject Identifier
Visit Description
Treatment Period ABC Visit XYZ
Upload the source documents for all data requested in this eCRF (e.g., labs, study results) as well as the admission History and Physical Examination findings and the Discharge Summary.
CLINICAL PRESENTATION
Date and time of arrhythmic event : Day Month Year Hr:Min(00:00 - 23:59)
Did event include cardiac arrest? (Y) Yes (N) No [NK] Not Known
If yes, was CPR or shock delivered? (Y) Yes (N) No [NK] Not Known
What was heart rate at time of presentation? beats/minute [NK] Not Known
PAST MEDICAL HISTORY
Did subject have a prior history of any of the following: Arrhythmia? (Y) Yes (N) No [NK] Not Known Cardiomyopathy? (Y) Yes (N) No [NK] Not Known Syncope with exercise? (Y) Yes (N) No [NK] Not Known ECG abnormality? (Y) Yes (N) No [NK] Not Known QT prolongation? (Y) Yes (N) No [NK] Not Known
Is there a family hx for unexplained sudden death or QT prolongation? (Y) Yes (N) No [NK] Not Known SYMPTOMS
Chest pain (Y) Yes (N) No [NK] Not Known
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Visit Description
Treatment Period ABC Visit XYZ
Syncope (Y) Yes (N) No [NK] Not Known
Presyncope (Y) Yes (N) No [NK] Not Known
Heart failure (Y) Yes (N) No [NK] Not Known
If yes, complete Heart Failure eCRF
Seizures (Y) Yes (N) No [NK] Not Known
Other (Y) Yes (N) No [NK] Not Known specify: ______
ECG STANDARD 12-LEAD
Was an ECG Performed? (Y) Yes (N) No [NK] Not Known
If Yes, date and time of ECG? : Day Month Year Hr:Min (00:00 – 23:59) Upload available ECGs. If only one ECG slot available, insert ECG that best characterizes the arrhythmic event. Companies to consider adding ability to insert more ECGs as appropriate.
RHYTHM all that apply:
heart rate ______beats/minute [NK] Not Known
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Visit Description
Treatment Period ABC Visit XYZ
Marked bradycardia (heart rate less than 40 beats/minute
Narrow QRS tachycardia (heart rate greater than 120 beats/minute)
First degree AV Block
Type 2 second degree AV block
Third degree AV block
Atrial flutter
Atrial fibrillation
acute
chronic
Ventricular tachycardia, sustained
Ventricular tachycardia, non-sustained
Ventricular fibrillation
Torsade de Pointes
QTc greater than 500 msec
Other abnormal rhythm,
Specify:___
If no ECG was performed, what was the clinical ______diagnosis of the arrhythmia(s)? Page 3 ARRHYTHMIAS Protocol Identifier Subject Identifier
Visit Description
Treatment Period ABC Visit XYZ
DIAGNOSTIC TRACING(S)
Is a rhythm / in-hospital telemetry strip available? (Y) Yes (N) No [NK] Not Known
If Yes, date and time of rhythm strip : Day Month Year Hr:Min(00-00-23:59) ------Is a pacemaker / ICD strip printout available? (Y) Yes (N) No [NK] Not Known
If Yes, date and time of pacemaker/ICD strip : Day Month Year Hr:Min(00-00-23:59) ------Is a loop recorder printout available? (Y) Yes (N) No [NK] Not Known
If Yes, date and time of loop recorder : Day Month Year Hr:Min(00-00-23:59) ------Is a Holter monitor report / printout available? (Y) Yes (N) No [NK] Not Known
If Yes, date and time of Holter monitor : Day Month Year Hr:Min(00-00-23:59) ------Is an Electrophysiology Study (EP) report available? (Y) Yes (N) No [NK] Not Known
If Yes, date and time of Electrophysiology study : Day Month Year Hr:Min(00-00-23:59) ------
Page 4 ARRHYTHMIAS Protocol Identifier Subject Identifier
Visit Description
Treatment Period ABC Visit XYZ
LABORATORY RESULT DATA Are there any relevant chemistry labs within (Y) Yes (N) No [NK] Not Known 24 hours of event (before or after event) If Yes, complete below: Note: Enter ‘NR’ if the laboratory results are not available to report or if a lab error occurred. Laboratory Name______Lab ID Address______Date Time Test Result Normal Ranges Lo High Unit Day Month Year Hr: Min w 00:00-23:59
e.g. 01 JAN 2012 13:25 Serum Creatinine 83 62 115 umol/l Potassium Magnesium Calcium Glucose List all labs available. Add lines for serial values of the same lab as needed. Are there thyroid function studies available? (Y) Yes (N) No [NK] Not Known (From within last year) If Yes, complete below: Note: Enter ‘NR’ if the laboratory results are not available to report or if a lab error occurred. Laboratory Name______Lab ID Address______Date Time Test Result Normal Ranges
Day Month Year Hr: Min Low High Unit 00:00-23:59 e.g. 01 JAN 2012 13:25 Serum Creatinine 83 62 115 umol/l Page 5 ARRHYTHMIAS Protocol Identifier Subject Identifier
Visit Description
Treatment Period ABC Visit XYZ
Serum TSH Serum total T4 concentration Serum total T3 concentration Serum free T4 concentration Serum free T3 concentration T3-resin uptake List all labs available. Add lines for serial values of the same lab as needed.
ECHOCARDIOGRAPHY Was an Echocardiogram performed? [Y] Yes [N] N [NK] Not Known
If Yes, complete the following:
Date and time of Echocardiogram: Day Month Year Hrs:Mins (00:00-23:59)
[Y] Yes [N] N [NK] Not Known Ejection Fraction Assessment (systolic function)? If Yes, record percentage %
Evidence of diastolic dysfunction? [Y] Yes [N] N [NK] Not Known
[Y] Yes [N] N [NK] Not Known Evidence of significant valvular disease? Page 6 ARRHYTHMIAS Protocol Identifier Subject Identifier
Visit Description
Treatment Period ABC Visit XYZ
Evidence of cardiac dilatation? [Y] Yes [N] N [NK] Not Known [A] Atrial [V] Ventricular [NK] If Yes, indicate which chamber(s) Not Known
Evidence of regional wall motion abnormality? [Y] Yes [N] N [NK] Not Known
Was a prior Echocardiogram performed? [Y] Yes [N] N [NK] Not Known
If Yes, complete the following:
Date and time of prior Echocardiogram: Day Month Year Hrs:Mins (00:00-23:59)
Prior Ejection Fraction Assessment (systolic [Y] Yes [N] N [NK] Not Known function)? % If Yes, record percentage
Prior evidence of diastolic dysfunction? [Y] Yes [N] N [NK] Not Known
Evidence of significant valvular disease? [Y] Yes [N] N [NK] Not Known
Evidence of cardiac dilatation? [Y] Yes [N] N [NK] Not Known If Yes, indicate which chamber(s) [A] Atrial [V] Ventricular [NK]
Page 7 ARRHYTHMIAS Protocol Identifier Subject Identifier
Visit Description
Treatment Period ABC Visit XYZ
Not Known
Evidence of regional wall motion abnormality? [Y] Yes [N] N [NK] Not Known
MUGA
Was a Multiple Gated Acquisition Scan (MUGA) [Y] Yes [N] N [NK] Not Known performed?
If Yes, complete the following:
Date and time of MUGA: Day Month Year Hrs:Mins (00:00-23:59)
Ejection Fraction Assessment? [Y] Yes [N] N [NK] Not Known
% If Yes, record percentage
Evidence of wall motion abnormalities? [Y] Yes [N] N [NK] Not Known
Was a prior Multiple Gated Acquisition Scan [Y] Yes [N] N [NK] Not Known (MUGA) performed?
If Yes, complete the following:
Date and time of prior MUGA: Day Month Year Hrs:Mins
Page 8 ARRHYTHMIAS Protocol Identifier Subject Identifier
Visit Description
Treatment Period ABC Visit XYZ
(00:00-23:59)
[Y] Yes [N] N [NK] Not Known Prior Ejection Fraction Assessment?
If Yes, record percentage %
Evidence of wall motion abnormalities? [Y] Yes [N] N [NK] Not Known
HOSPITALIZATIONHOSPITALIZATION
Was subject hospitalized due to arrhythmias? (Y) Yes (N) No [NK] Not Known
If Yes, admission date and time : Day Month Year Hr:Min(00-00-23:59) THERAPY
Was any of the following therapy administered?
Cardioversion Pharmacological (Y) Yes (N) No [NK] Not Known
Supplemental: consider listing specific classes, acute / chronic pharmacotherapy to treat the arrhythmia
Electrical (Y) Yes (N) No [NK] Not Known
Defibrillation (Y) Yes (N) No [NK] Not Known
Page 9 ARRHYTHMIAS Protocol Identifier Subject Identifier
Visit Description
Treatment Period ABC Visit XYZ
Defibrillator/pacemaker insertion (Y) Yes (N) No [NK] Not Known
Radiofrequency ablation (Y) Yes (N) No [NK] Not Known
Surgery (e.g., MAZE procedure) (Y) Yes (N) No [NK] Not Known
Any sequelae as a result of the arrhythmia? (Y) Yes (N) No [NK] Not Known
If Yes, specify______
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